Methylprednisolone for Knee Arthritis

Recruiting at 1 trial location

Overseen By Ajay Premkumar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Significant injuries, Minors, Immune suppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 days

101 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether a short-term course of medication can reduce pain, nausea, and the need for opioids in patients after knee replacement surgery. The study involves patients who are having knee replacement surgery and aims to see if this medication can improve their recovery by reducing inflammation. Certain medications have been shown to improve recovery and reduce nausea in various surgical settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have pre-existing immune suppression, you may not be eligible to participate.

What evidence supports the effectiveness of the drug methylprednisolone for knee arthritis?

Methylprednisolone has been shown to be effective in managing pain and inflammation in conditions like diskogenic back pain and rheumatic diseases, suggesting it may help with knee arthritis as well. Additionally, the drug is well-absorbed in the body, making it a reliable option for high-dose therapy. ^{1 2 3 4 5}

Is methylprednisolone generally safe for humans?

Methylprednisolone, used in various forms like Medrol and Solu-Medrol, has been studied for safety in humans. In a study with healthy volunteers, no adverse reactions were recorded, and it was found to be safe for high-dose therapy. However, accidental injection into the eye can cause serious damage, highlighting the importance of proper administration. ^{1 3 4 5 6}

How does the drug methylprednisolone differ from other treatments for knee arthritis?

Methylprednisolone is a corticosteroid that reduces inflammation and is often used in various forms, such as injections, to manage pain and swelling. Its unique feature is the ability to provide rapid relief by directly targeting inflamed areas, which can be particularly beneficial when other conservative treatments have not been effective. ^{1 2 3 6 7}

Research Team

Ajay Premkumar, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for patients aged 18 to 95 who are undergoing their first total knee replacement due to severe knee arthritis. It's not suitable for those with other conditions that might affect the surgery or recovery.

Inclusion Criteria

I am having a knee replacement due to arthritis.

I am between 18 and 95 years old.

Exclusion Criteria

I am a minor and cannot legally consent for myself.

Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

I have a condition that weakens my immune system, and taking steroids could be harmful.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee replacement surgery followed by a 6-day course of Medrol Dose Pak or standard care with a single dose of dexamethasone

6 days

Daily monitoring for 7 days post-surgery

Follow-up

Participants are monitored for pain, nausea, range of motion, and opioid consumption for six weeks post-surgery

6 weeks

Regular clinic visits for evaluation

Treatment Details

Interventions

• Methylprednisolone

Trial Overview The study tests if a short-term steroid medication called Medrol Dose Pak can reduce pain, nausea, and opioid use after knee replacement surgery compared to standard post-surgery care.

Participant Groups

Group I: Experimental Group: Medrol Dose Experimental Treatment 1 Intervention

The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.

Group II: Control Group: Standard of Care Active Control 1 Intervention

Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Findings from Research

Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.

This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]

Intramedullary injection of methylprednisolone acetate (Depo-Medrol) effectively treats unicameral cysts in children, as demonstrated in a rabbit model where the drug was injected into the tibia.

The study found that while serum levels of methylprednisolone rose quickly, indicating systemic absorption, there were no significant local histological changes such as fibroblastic proliferation or neovascularization, suggesting that the mechanism of action may not involve direct tissue alteration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits. Colville, MR., Aronson, DD., Prcevski, P., et al.[2019]

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

The study found that the new high-dose (100 mg) methylprednisolone tablet has an absolute bioavailability of 82%, indicating it is effectively absorbed in the body when taken orally.

No adverse drug reactions were reported, and the tablet can safely substitute for intravenous methylprednisolone in high-dose therapy, as it produced expected changes in blood neutrophil counts without significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absolute bioavailability of a new high dose methylprednisolone tablet formulation. Groenewoud, G., Hundt, HK., Luus, HG., et al.[2013]

In a study of 901 patients with relapsing-remitting multiple sclerosis, methylprednisolone (MP) pulse therapy was administered with a mean frequency of 4 times, showing that the majority of patients received treatment multiple times, indicating its common use in managing acute exacerbations.

The study found that female patients were approximately 3.7 times more likely to seek MP pulse therapy compared to male patients, suggesting a gender difference in treatment-seeking behavior for MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. Tolou-Ghamari, Z., Shaygannejad, V., Ashtari, F.[2022]

A case of conjunctival necrosis occurred in an 82-year-old patient after an inadvertent subconjunctival injection of methylprednisolone following cataract surgery, highlighting a serious complication associated with this medication.

Methylprednisolone is not approved for use in the eye, and this incident underscores the risks of using unapproved medications in ophthalmic procedures, emphasizing the need for caution and adherence to approved treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. van Zyl, LM., Hill, JJ.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Absolute bioavailability of a new high dose methylprednisolone tablet formulation. [2013]

5. Ukraine pubmed.ncbi.nlm.nih.gov

[A comparative evaluation of the efficacy of peroral and intravenous pulse therapy with methylprednisolone in rheumatic diseases]. [2016]

6. Iran pubmed.ncbi.nlm.nih.gov

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. [2021]